Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients

NCT ID: NCT05748977

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-03-20

Brief Summary

Chronic obstructive pulmonary disease is heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive ,airflow obstruction.

There are network meta analysis to compare the efficacy and safety of short acting bronchodilators Vs long acting agents in treatment of COPD

Detailed Description

Aim of the work1.To compare efficacy of short acting beta 2 agonists ,short acting antimuscrinic agents and beclomethasone versus long acting beta 2 agonist,short acting antimuscurnic agents and fluticasone.- Type of the study: This study is a randomized controlled trail 2.4. 2- Study Setting: Present study will be conducted in chest outpatient clinic Chest department Assiut University hospital 2.4. 3- Study subjects: Frequent exacerbator COPD patients Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group).

Main outcome variable is difference in dyspnoea scores in frequent exacerbator COPD patients receiving long-acting steroids vs. short acting treatment. Based on previous systematic review we expected to find significant improvement in long-acting treatment group (large effect size). Data will be collected through: patients diagnosed COPD by different investigations (history, examinations spirometry) have recurrent exacerbations, some patients receiving short acting beta 2 agonists, short acting anti-muscurnic agents and beclomethasone versus long acting agents and fluticasone then all patients followed using dyspnea scores, CCQ, saint George questionnaire which assess heath related quality of life.

Conditions

Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SABA,SAMA ICS

Group Type: EXPERIMENTAL

SABA SAMA ICS Vs LABA LAMA ICs

Intervention Type: DRUG

Short acting agents,long acting agents ,ics

LABA,LAMA ICS

Group Type: EXPERIMENTAL

SABA SAMA ICS Vs LABA LAMA ICs

Intervention Type: DRUG

Short acting agents,long acting agents ,ics

Interventions

SABA SAMA ICS Vs LABA LAMA ICs

Short acting agents,long acting agents ,ics

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All frequent exacerabator copd patients

Exclusion Criteria

• patients less than 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nermen Abuelkassem

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nermen M abuelkassem, Lecturer

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

Nermen Mohammed Abuelkassem

Asyut, , Egypt

Countries

Egypt

Central Contacts

nermen M abuelkassem, lecturer

Role: CONTACT

nermenabuelkassem@gmail.com

01000767713

mohammed gamal Abdelrahman, lecturer

Role: CONTACT

dr.mga2011@yahoo.com

01026600071

Facility Contacts

Mohammed Gamal Abdalrahman Khalaf

Role: primary

dr.mga2011@yahoo.com

01026600071

Other Identifiers

SABA,SAMA versus LABA,LAMAcopd

Identifier Type: -

Identifier Source: org_study_id